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Clinical trial assistant (switzerland)

Nyon
Cordis Corporation
Inserat online seit: 15 April
Beschreibung

Selution, in partnership with Cordis, specializes in the development of ground-breaking technology and commercialization of advanced drug device combination products for the treatment of coronary and peripheral artery disease. Our mission is to revolutionize healthcare by creating next-generation solutions that address unmet and critical medical needs. The Clinical Trial Assistant (CTA) provides administrative and operational support to the Clinical Operations team to ensure clinical trials are conducted in compliance with regulatory requirements, including Good Clinical Practice (GCP), ISO 14155, EU MDR, and company standard operating procedures (SOPs). The CTA plays a critical role in essential administrative and operational tasks, such as maintaining trial documentation, supporting site communications, and ensuring inspection readiness throughout the study lifecycle. Responsibilities Assist in the preparation, tracking, and maintenance of essential trial documents (e.g., Trial Master File (TMF), Investigator Site Files (ISF)) Support study start-up, maintenance, and close-out activities Coordinate and track regulatory documents, site contracts, and ethics submissions Maintain tracking tools, spreadsheets, and databases Schedule meetings, prepare agendas, and distribute meeting minutes Support clinical trial teams with document review and version control Assist with site communication and follow-up on outstanding documentation Track clinical supplies and study materials as needed Ensure proper filing and archiving of study documentation Support audit and inspection preparation activities Assist with vendor coordination and documentation tracking Required Qualifications Bachelor’s degree in Life Sciences, Nursing, Pharmacy, Public Health, or related field preferred Equivalent combination of education and experience may be considered 2 years of experience in clinical research, healthcare, or pharmaceutical environment preferred Internship or prior exposure to clinical trials is a plus Competencies & Skills Knowledge of ICH-GCP guidelines and regulatory requirements Strong organizational and documentation skills Attention to detail and accuracy of output Problem solving attitude Skill in prioritizing workflow to meet deadlines and manage multiple tasks Strong written and verbal communication skills Proficiency in Microsoft Office (Word, Excel, PowerPoint, Outlook) Familiarity with CTMS, eTMF systems preferred High energy Enjoys and has a track record of operating independently Capable of working across multiple time zones including Europe Fluent in English, additional language is a plus, but not required Physical Requirements • Candidate must be able to work effectively in a hybrid setting, based near Nyon, CH • Must be able to travel up to 10% Cordis is proud to be an equal opportunity employer and is committed to providing equal opportunity for all teammates and applicants. At Cordis, our teammates all bring different strengths, experiences, and backgrounds, who share a passion for improving people's lives. Diversity not only includes race and gender identity, but also age, disability status, veteran status, sexual orientation, religion, and many other parts of one’s identity. All our teammates’ points of view are key to our success, and we believe inclusion is everyone's responsibility. Together, we strive to create and maintain working and learning environments that are inclusive, equitable and welcoming.

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